9828 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations 

PART 51—REQUIREMENTS FOR 

PREPARATION, ADOPTION, AND 

SUBMITTAL OF IMPLEMENTATION 

PLANS 

■ 1. The authority citation for part 51 

continues to read as follows: 

Authority: 42 U.S.C. 7401, 7411, 7412, 

7413, 7414, 7470–7479, 7501–7508, 7601, 

and 7602. 

§ 51.100—[Amended] 

■ 2. Section 51.100 is amended at the 

end of paragraph (s)(1) introductory text 

by removing the words ‘‘methyl acetate, 

1,1,1,2,2,3,3-heptafluoro-3-methoxypropane (n-C3F7OCH3, HFE–7000), 3- 

ethoxy- 1,1,1,2,3,4,4,5,5,6,6,6- 

dodecafluoro-2-(trifluoromethyl) hexane 

(HFE–7500), 1,1,1,2,3,3,3- 

heptafluoropropane (HFC 227ea), 

methyl formate (HCOOCH3), (1) 

1,1,1,2,2,3,4,5,5,5-decafluoro-3- 

methoxy-4-trifluoromethyl-pentane 

(HFE–7300); propylene carbonate; 

dimethyl carbonate; trans-1,3,3,3- 

tetrafluoropropene; and perfluorocarbon 

compounds which fall into these 

classes:’’ and adding in their place the 

words ‘‘methyl acetate; 1,1,1,2,2,3,3- 

heptafluoro-3-methoxy-propane (nC3F7OCH3, HFE–7000); 3-ethoxy1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2- 

(trifluoromethyl) hexane (HFE–7500); 

1,1,1,2,3,3,3-heptafluoropropane (HFC 

227ea); methyl formate (HCOOCH3); 

1,1,1,2,2,3,4,5,5,5-decafluoro-3- 

methoxy-4-trifluoromethyl-pentane 

(HFE–7300); propylene carbonate; 

dimethyl carbonate; trans-1,3,3,3- 

tetrafluoropropene; HCF2OCF2H (HFE– 

134); HCF2OCF2OCF2H (HFE–236cal2); 

HCF2OCF2CF2OCF2H (HFE–338pcc13); 

HCF2OCF2OCF2CF2OCF2H (H-Galden 

1040x or H-Galden ZT 130 (or 150 or 

180)); and perfluorocarbon compounds 

which fall into these classes:’’. 

[FR Doc. 2013–03057 Filed 2–11–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2009–0648; FRL–9728–7] 

Approval and Promulgation of 

Implementation Plans; New Mexico; 

Albuquerque/Bernalillo County: 

Infrastructure and Interstate Transport 

Requirements for the 1997 and 2008 

Ozone and the 1997 and 2006 PM2.5

NAAQS 

Correction 

■ In rule document 2012–22975 

beginning on page 58032 in the issue of 

Wednesday, September 19, 2012, make 

the following corrections: 

§ 52.1620 [Corrected] 

Due to an error in the EPA approval 

date, the table entitled ‘‘EPA– 

APPROVED ALBUQUERQUE/ 

BERNALILLO COUNTY, NM 

REGULATIONS’’ on pages 58034 and 

58035 is being reprinted in its entirety 

to read as follows: 

EPA-APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS

State citation Title/subject 

State 

approval/effective date EPA approval date Explanation 

New Mexico Administrative Code (NMAC) Title 20—Environment Protection, Chapter 11—Albuquerque/Bernalillo County Air Quality 

Control Board 

*******

Part 8 (20.11.8 NMAC) ........... Ambient Air Quality Standards.8/12/2009 September 19, 2012, [Insert 

FR page number where 

document begins].

*******

Part 61 (20.11.61 NMAC) ....... Prevention of Significant Deterioration.1/10/2011 September 19, 2012, [Insert 

FR page number where 

document begins].

*******

[FR Doc. C1–2012–22975 Filed 2–11–13; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. CDC–2012–0002] 

RIN 0920–AA47 

Establishment of User Fees for 

Filovirus Testing of Nonhuman Primate 

Liver Samples 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), is amending 

regulations for the importation of live 

nonhuman primates (NHPs) by 

establishing a user fee for filovirus 

testing of all nonhuman primates that 

die during the HHS/CDC-required 31- 

day quarantine period for any reason 

other than trauma. We are amending the 

regulations to establish a filovirus 

testing service at HHS/CDC, because 


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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations 9829 

testing is no longer being offered by the 

only private, commercial laboratory that 

previously performed these tests. This 

testing service will be funded through 

user fees. 

DATES: This final rule is effective on 

March 14, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Ashley A. Marrone, J.D., Division of 

Global Migration and Quarantine, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., 

Mailstop E–03, Atlanta, Georgia 30333, 

telephone, 404–498–1600. 

SUPPLEMENTARY INFORMATION: This final 

rule is organized as follows: 

Table of Contents 

I. Background 

II. Public Comment Summary and Responses 

A. Public Comments of General Support 

B. Public Comments Regarding Analysis of 

the Rule 

III. Alternatives Considered 

IV. Payment Instructions 

V. Regulatory Analyses 

A. Required Regulatory Analyses under 

Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Small Business Regulatory Enforcement 

Fairness Act of 1996 

D. Paperwork Reduction Act of 1995 

E. National Environmental Policy Act 

(NEPA) 

F. Civil Justice Reform (Executive Order 

12988) 

G. Executive Order 13132 (Federalism) 

H. Plain Language Act of 2010 

I. Background 

On February 10, 2012, we published 

a notice of proposed rulemaking 

(NPRM) in the Federal Register (77 FR 

7109) that provided the background, 

rationale, description of the services and 

activities covered by the user fee, an 

analysis of the user fee charge (cost to 

the government), and payment 

instructions. On the same date, we 

published a companion Direct Final 

Rule (DFR) (77 FR 6981). In both the 

NPRM and DFR, we stated that if we did 

not receive any significant adverse 

comments by April 10, 2012, we would 

publish a document in the Federal 

Register withdrawing the NPRM and 

confirming the effective date of the DFR 

within 30 days after the end of the 

comment period. 

Because the DFR contained an error in 

effective date and HHS/CDC received a 

significant adverse public comment, we 

published a correcting amendment in 

the Federal Register on June 15, 2012 

(77 FR 35878), withdrawing the DFR. 

II. Public Comment Summary and 

Responses 

HHS/CDC received four public 

comments on the NPRM. Three of the 

commenters expressed strong support 

for the proposal, and one commenter 

questioned our analysis of the rule. 

HHS/CDC did not receive any public 

comments objecting to the amount of 

the user fee, which is $540.00 USD. The 

comments and HHS/CDC responses are 

summarized below. 

A. Public Comments of General Support 

One commenter indicated that the 

user fees would be a good idea because 

the testing of nonhuman primate liver 

samples for filovirus infection is 

essential for public health and safety. 

The commenter stated that the amount 

of the user fee is not exorbitant and will 

allow the government to continue to test 

NHPs. This commenter also expressed 

concern that the agency would be 

unable to continue to test NHPs absent 

reimbursement. Finally, the commenter 

indicated his/her support for the testing 

of animals that pose a threat to human 

life. A second commenter noted that it 

is the duty of the federal government to 

protect the health and welfare of its 

citizens from preventable dangers and 

that failure to do so would constitute a 

dereliction of duty. Further, this 

commenter fully supported what he/she 

referred to as a ‘‘reasonable fee.’’ 

HHS/CDC Response. HHS/CDC 

thanks the commenters for their 

comments. 

A third commenter agreed that 

establishing user fees for filovirus 

testing of nonhuman primate liver 

samples was a necessary step toward 

protecting public health. While this 

commenter offered ‘‘100%’’ support for 

the regulation, the commenter also 

questioned whether HHS/CDC’s costs 

for storing records could increase the 

amount of the user fee in the future. 

HHS/CDC Response. Although HHS/ 

CDC has only recently begun to offer 

this testing service, it has collected and 

maintained filovirus test results from 

importers since the beginning of the 

testing requirement and expects to 

continue do so in the future. Because 

maintaining test results are an expense 

that HHS/CDC had already assumed, 

these costs were not included in the 

calculations of the user fee. HHS/CDC 

does not expect to attempt to recoup 

these costs in the future. 

B. Public Comments Regarding Analysis 

of the Rule 

A commenter stated that CDC did not 

provide an analysis of the filovirus 

testing market, including the nature and 

extent of current and future demand for 

filovirus testing. The commenter 

requested that HHS/CDC consider and 

address the long-term prospects of the 

filovirus testing market. Specifically, the 

commenter stated that if the market is 

minimal, it would be appropriate for the 

government to administer and perform 

the testing. On the other hand, if the 

market was much larger, then it may be 

in the interest of the public and the 

government to incentivize the 

construction of private laboratory 

facilities for the purpose of filovirus 

testing, thereby allowing the 

commercial market to serve the need of 

importers. 

HHS/CDC Response. HHS/CDC 

disagrees with this comment. While not 

labeled specifically as a market analysis 

in the NPRM, the components of a 

market analysis were included in the 

preamble of the NPRM. Demand and 

market size, as calculated by revenues 

and numbers of requests for filovirus 

tests, were included in section III 

‘‘Rationale for Proposal’’ of the NPRM 

and were based on the observed demand 

noted by, and fees charged by, the 

commercial laboratory that performed 

this service since 1990. 

In section VI ‘‘Analysis of User Fee 

Charge (Cost to the Government)’’ of the 

NPRM, HHS/CDC noted that during the 

past five years, our records indicated 

that there were approximately 100–150 

requests per year, generating revenues of 

$50,000 to $75,000 a year. 

The issue of future demand was also 

implicitly addressed in the NPRM, 

where we noted that the demand for 

testing is driven by government 

requirements and the population of 

imported NHPs that drive the demand is 

limited by regulation to scientific, 

exhibition or educational purposes. 

Thus, we do not expect that market size 

and demand will change substantially 

in the long run. 

Regarding the commenter’s query 

about the size of the market, we note 

that regardless of whether the filovirus 

testing market is measured by requests 

(100–150) or revenues ($50,000 to 

$75,000 a year), it is, and will continue 

to be, a small market from a laboratory 

perspective. The market revenue 

generated by testing is too small to 

create demand specifically for a 

‘‘filovirus testing facility’’ because 

laboratories, especially the Biosafety 

Level 4 (BSL–4) laboratories needed for 

this type of testing, require large 

amounts of sunk capital. In this context, 

‘‘sunk capital’’ is intended to mean 

investments in laboratory-specific 

equipment and facilities that cannot be 

resold for other businesses or used for 

other purposes. As explained in the 

NPRM, the testing procedure requires a 

BSL–4 laboratory for specimen 

processing, reagent preparation, and the 

testing procedure. The forecast revenues 

from filovirus testing of $50,000 to 


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9830 Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations 

$75,000 a year would only be a fraction 

of the budget needed to sustain a BSL– 

4 type of facility needed to test for 

filoviruses. 

We note that the estimates in the 

NPRM of a per-test cost of $540.00 USD 

do not take into account the perspective 

of a commercial laboratory that would 

trade the costs and benefits of devoting 

laboratory space and resources to 

filovirus testing for other revenuegenerating tests and services they could 

offer. Finally, we note that no 

commercial entities have entered the 

market of antigen-capture filovirus 

testing since the original commercial 

laboratory stopped providing this 

service. 

Viewed as a whole, these factors 

(sunk capital required to perform such 

testing, limited market demand, and 

current lack of a commercial laboratory 

offering this service), were instrumental 

in shaping our view that there is likely 

no commercial laboratory that will enter 

this market in the immediate future. 

However, as indicated in the NPRM, 

nothing in this final rule prohibits a 

commercial laboratory from entering the 

market in the future. 

Next, the commenter raised a series of 

questions regarding long run actions 

that CDC can take to make filovirus 

testing viable commercially. 

Specifically, the commenter said, ‘‘it 

may be more appropriate to examine the 

data and other indicators to ensure that 

the agency is not overlooking any 

externalities.’’ 

HHS/CDC Response. As noted in the 

NPRM, there are no private laboratories 

engaged in filovirus testing at this time. 

If HHS/CDC were to provide the tests 

free-of-charge, this would be a long-term 

disincentive for any commercial lab to 

enter the business because no 

commercial lab could compete with nofee testing. By implementing a fee, CDC 

is eliminating the nature of unfair 

government competition created by a 

price that may be below standard 

commercial market fees, or free. The fee 

HHS/CDC intends to charge is 

consistent with the fee previously 

charged by the one commercial 

laboratory performing this type of 

testing. Furthermore, as HHS/CDC 

stated in the NPRM and above, the 

action taken in this rulemaking is not 

intended to prohibit a private sector 

facility from developing the capability 

and offering this same service in the 

future. When considered together, the 

fee, the extensive investments needed to 

build and maintain BSL–4 type 

laboratories, and the small size of the 

filovirus testing market, indicate that 

CDC can take no other short-term or 

long-term actions to encourage a private 

market for filovirus testing. 

III. Alternatives Considered 

As stated earlier in the Preamble, 

HHS/CDC believes this testing is 

essential to protect public health and 

safety. If this testing is not provided, it 

will have a disruptive impact on 

imports of NHPs for science, 

educational, and exhibition purposes, 

that would remain in quarantine absent 

a negative test result. 

When HHS/CDC learned that the sole 

commercial laboratory performing this 

testing was no longer offering the 

testing, we considered several 

alternatives to meet the testing 

requirement. One alternative was to 

wait for another commercial laboratory 

to begin performing the testing. 

However, as stated previously in the 

Preamble, another laboratory has not 

entered the market since the previous 

laboratory stopped performing this 

testing. Indeed, to date, no laboratory 

has begun offering this service in 

response to the NPRM. 

Another alternative that HHS/CDC 

considered was to perform the testing in 

HHS/CDC laboratories at no cost. 

However, as commenters have noted, 

the cost burden of performing the 

testing without compensation may 

prevent the Agency from performing the 

testing indefinitely. Further, as we 

stated previously in the Preamble, 

should HHS/CDC offer this testing at no 

charge, it would create a disincentive to 

the private sector to enter the market. 

Finally, HHS/CDC considered offering 

a filovirus testing service and 

establishing a user fee to cover the cost 

of the testing. This is the alternative that 

HHS/CDC chose. 

IV. Payment Instructions 

As of the effective date of this rule, 

importers should submit a check or 

money order in the amount of $540.00 

USD made payable to Centers for 

Disease Control and Prevention for each 

test conducted at the time that 

specimens are submitted to the CDC for 

testing. The check(s) should be sent to 

Centers for Disease Control and 

Prevention, P.O. Box 15580, Atlanta, GA 

30333. 

V. Regulatory Analyses 

A. Required Regulatory Analyses Under 

Executive Orders 12866 and 13563 

We have examined the impacts of the 

final rule under Executive Orders 12866 

and 13563, which direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages, 

distributive impacts, and equity). 

Because the purpose of this rule is to 

provide a framework to determine a fair 

fee to charge for a service that has 

become unavailable in private, 

commercial markets within the United 

States, we have determined that the rule 

will not violate the intent of either of 

the Executive Orders because it will in 

no way prevent a private entity from 

entering the field and providing a 

similar, privatized service. If any private 

entity expresses an interest in providing 

this service, we strongly encourage them 

to do so. 

This rule is being treated as ‘‘not 

significant’’ under EO 12866. We are 

amending 42 CFR 71.53 to establish a 

filovirus testing service at HHS/CDC, 

because testing is no longer being 

offered by the only private, commercial 

laboratory that previously performed 

these tests. Thus, the rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

B. Regulatory Flexibility Act 

We have examined the impacts of the 

final rule under the Regulatory 

Flexibility Act (5 U.S.C. 601–612). 

Unless we certify that the rule is not 

expected to have a significant economic 

impact on a substantial number of small 

entities, the Regulatory Flexibility Act 

(RFA), as amended by the Small 

Business Regulatory Enforcement 

Fairness Act (SBREFA), requires 

agencies to analyze regulatory options 

that would minimize any significant 

economic impact of a rule on small 

entities. We certify that this rule will 

not have a significant economic impact 

on a substantial number of small entities 

within the meaning of the RFA. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

This regulatory action is not a major 

rule as defined by Sec. 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This final rule will 

not result in an annual effect on the 

economy of $100,000,000 or more; a 

major increase in cost or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 


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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Rules and Regulations 9831 

D. The Paperwork Reduction Act of 

1995 

HHS/CDC has reviewed the 

information collection requirements of 

the final rule and has determined that 

the information collection requested in 

the final rule is already approved by the 

Office of Management and Budget 

(OMB) under OMB Control No. 0920– 

0263, expiration date June 30, 2014. The 

final rule does not contain any new data 

collection or record keeping 

requirements. 

E. National Environmental Policy Act 

(NEPA) 

Pursuant to 48 FR 9374 (list of HHS/ 

CDC program actions that are 

categorically excluded from the NEPA 

environmental review process), HHS/ 

CDC has determined that this action 

does not qualify for a categorical 

exclusion. In the absence of an 

applicable categorical exclusion, the 

Director, CDC, has determined that 

provisions amending 42 CFR 71.53 will 

not have a significant impact on the 

human environment. Therefore, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

F. Civil Justice Reform (Executive Order 

12988) 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. Under this final rule: (1) 

All State and local laws and regulations 

that are inconsistent with this rule will 

be preempted; (2) no retroactive effect 

will be given to this rule; and (3) 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. 

G. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding Federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS/CDC 

attempted to use plain language in 

promulgating this rule consistent with 

the Federal Plain Writing Act guidelines 

and requested comment from the public 

on this topic. HHS/CDC did not receive 

any public comment to this request. 

List of Subjects in 42 CFR Part 71 

Communicable diseases, Public 

health, Quarantine, Reporting and 

recordkeeping requirements, User fees, 

Testing. 

For the reasons discussed in the 

preamble, the Centers for Disease 

Control and Prevention amends 42 CFR 

part 71 as follows: 

PART 71—FOREIGN QUARANTINE 

■ 1. The authority citation for 42 CFR 

part 71 continues to read as follows: 

Authority: Sec. 311 of the Public Health 

Service (PHS) Act, as amended (42 U.S.C. 

243), secs. 361–369, PHS Act, as amended 

(42 U.S.C. 264–272). 

Subpart F—Importations 

■ 2. In § 71.53, add paragraph (j) to read 

as follows: 

§ 71.53 Nonhuman primates. 

* * * * * 

(j) Filovirus testing fee. (1) Nonhuman primate importers shall be 

charged a fee for filovirus testing of nonhuman primate liver samples submitted 

to the Centers for Disease Control and 

Prevention (CDC). 

(2) The fee shall be based on the cost 

of reagents and other materials 

necessary to perform the testing; the use 

of the laboratory testing facility; 

irradiation for inactivation of the 

sample; personnel costs associated with 

performance of the laboratory tests; and 

administrative costs for test planning, 

review of assay results, and 

dissemination of test results. 

(3) An up-to-date fee schedule is 

available from the Division of Global 

Migration & Quarantine, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, Atlanta, Georgia 30333. 

Any changes in the fee schedule will be 

published in the Federal Register. 

(4) The fee must be paid in U.S. 

Dollars at the time that the importer 

submits the specimens to HHS/CDC for 

testing. 

Dated: February 4, 2013. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2013–02825 Filed 2–11–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2013–0002] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Associate 

Administrator for Mitigation has 

resolved any appeals resulting from this 

notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 


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